Pharmaceutical Validation Specialist

Stark Pharma Solutions Inc; North Carolina; On-site; USD 75,000 - 110,000; Full time

Job summary

A pharmaceutical company in Greenville, NC is seeking a Pharmaceutical Validation Specialist to manage protocol templates and ensure compliance with industry standards. The ideal candidate will have over 5 years of experience, particularly in Media Fill Validation and a strong background in regulatory requirements. This role requires collaboration with cross-functional teams to maintain project schedules and documentation.

Qualifications

• 5+ years of industry experience, including hands-on experience with Media Fill Validation.
• Proven expertise in Commissioning & Qualification (C&Q) and Validation activities.
• Strong background in authoring and executing protocols.

Responsibilities

• Draft and maintain protocol templates and reports.
• Manage central trackers for protocol reviews and approvals.
• Coordinate feedback cycles with stakeholders and update documentation.

Skills

Technical writing

Interpersonal skills

Problem-solving

Attention to detail

Education

Bachelor's Degree in a relevant scientific or engineering discipline

Job description

Job Title: Pharmaceutical Validation Specialist

Location: Greenville, NC

Experience: 5+ years

Duration: 12+ months

Job Responsibilities

• Draft and maintain protocol templates, media fill summaries, and standardized reports.
• Populate bracketing documentation tables and support protocol generation.
• Manage central trackers for protocol reviews, approvals, and interventions.
• Coordinate feedback cycles with site and global stakeholders; update documentation accordingly.
• Provide execution support to ensure project milestones and deliverables remain on schedule.
• Collaborate cross-functionally with Validation and QA leads to support documentation and onsite activities.

Requirements

• Bachelor's Degree in a relevant scientific or engineering discipline.
• Minimum 5+ years of industry experience, including hands-on experience with Media Fill Validation.
• Proven expertise in Commissioning & Qualification (C&Q) and Validation activities.
• Strong background in authoring and executing protocols, as well as drafting media fill summaries and reports.
• Experience working in a pharmaceutical / FDA-regulated manufacturing environment.
• Solid understanding of cGMP requirements, facility/equipment validation, and regulatory expectations.
• Excellent technical writing skills with the ability to communicate clearly and persuasively.
• Strong interpersonal skills with demonstrated ability to interact effectively across all levels of the organization.
• Ability to work collaboratively within cross-functional teams.
• High attention to detail, problem-solving ability, and critical thinking skills.